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HomeMy WebLinkAbout#5378_2_2014_final INSPECTION REPORT ROUTING SHEET To be attached to all inspection reports in-house only. Laboratory Cert. #: 5378 Laboratory Name: DAK Americas Cedar Creek Inspection Type: Field Maintenance Inspector Name(s): Tonja Springer Inspection Date: February 18, 2014 Date Report Completed: March 14, 2014 Date Forwarded to Reviewer: March 14, 2014 Reviewed by: Nick Jones Date Review Completed: March 20, 2014 Cover Letter to use: Insp. Initial Insp. Reg. Insp. No Finding Insp. CP Corrected Unit Supervisor/Chemist III: Dana Satterwhite Date Received: 3/25/2014 Date Forwarded to Linda: 4/24/2014 Date Mailed: 4/24/2014 _____________________________________________________________________ Tonja – Please send a copy of this report to Belinda Henson in FRO. On-Site Inspection Report LABORATORY NAME: DAK Americas Cedar Creek WATER QUALITY PERMIT # : NC0003719 ADDRESS: 3216 Cedar Creek Rd. Fayetteville, NC 28312 CERTIFICATE #: 5378 DATE OF INSPECTION: February 18, 2014 TYPE OF INSPECTION: Field Maintenance AUDITOR(S): Tonja Springer LOCAL PERSON(S) CONTACTED: Donald Allbright I. INTRODUCTION: This laboratory was inspected by a representative of the North Carolina Wastewater/Groundwater Laboratory Certification (NC WW/GW LC) program to verify its compliance with the requirements of 15A NCAC 2H .0800 for the analysis of environmental samples. II. GENERAL COMMENTS: The laboratory was clean and well organized. The facility has all the equipment necessary to perform the analyses. Current quality assurance policies for Field Laboratories and approved procedures for the analysis of the facility’s currently certified parameters were provided at the time of the inspection. Contracted analyses are performed by TBL Environmental Laboratory, Inc. (Certification #37) and Environment 1, Inc. (Certification #10). The requirement associated with Finding C has been implemented by our program since the last inspection. III. FINDINGS, REQUIREMENTS, COMMENTS AND RECOMMENDATIONS: Total Residual Chlorine – Standard Methods, 4500 Cl G-2000 Dissolved Oxygen – Standard Methods, 4500 O G-2001 Temperature – Standard Methods, 2550 B-2000 pH – Standard Methods, 4500 H+B-2000 Recommendation: The laboratory’s data defensibility would be improved with the addition of an instrument maintenance log. This can be as simple as a description in a comment box on a benchsheet. One example of instrument maintenance is replacing a bulb on the Total Residual Chlorine meter. Page 2 #5378 DAK Americas Cedar Creek Comment: Instrument identification and facility name for the meters used for Temperature, pH, Dissolved Oxygen and Total Residual Chlorine were not documented on the benchsheet. The NC WW/GW LC Approved Procedure for the Analysis of Total Residual Chlorine, the NC WW/GW LC Approved Procedure for the Analysis of Dissolved Oxygen, the NC WW/GW LC Approved Procedure for the Analysis of Temperature, and the NC WW/GW LC Approved Procedure for the Analysis of pH documents state: The following must be documented in indelible ink whenever sample analysis is performed: Instrument identification and facility name. This requirement is a new policy that has been implemented by our program since the last inspection. Demonstration of acceptable corrective action (i.e., an updated benchsheet which included the instrument ID and facility name) was received by email on 2/25/2014. No further response is necessary for this finding. Comment: Several instances of writing over a number as a means of error correction were observed. The Quality Assurance Policies for Field Laboratories document states: All documentation errors must be corrected by drawing a single line through the error so that the original entry remains legible. Entries shall not be obliterated by erasures or markings. Wite-Out®, correction tape or similar products designed to obliterate documentation are not to be used. Write the correction adjacent to the error. The correction must be initialed by the responsible individual and the date of change documented. All data and log entries must be written in indelible ink. Pencil entries are not acceptable. Demonstration of acceptable corrective action (i.e., an updated benchsheet which included error correction policy) was received by email on 2/25/2014. No further response is necessary for this finding. Total Residual Chlorine – Standard Methods, 4500 Cl G-2000 pH – Standard Methods, 4500 H+B-2000 Comment: The laboratory needs to increase the documentation of purchased materials and reagents, as well as documentation of standards and reagents prepared in the laboratory. The Quality Assurance Policies for Field Laboratories states: All chemicals, reagents, standards and consumables used by the laboratory must have the following information documented: Date Received, Date Opened (in use), Vendor, Lot Number, and Expiration Date. A system (e.g., traceable identifiers) must be in place that links standard/reagent preparation information to analytical batches in which the solutions are used. Documentation of solution preparation must include the analyst’s initials, date of preparation, the volume or weight of standard(s) used, the solvent and final volume of the solution. This information as well as the vendor and/or manufacturer, lot number, and expiration date must be retained for chemicals, reagents, standards and consumables used for a period of five years. Consumable materials such as pH buffers and lots of pre-made standards are included in this requirement. This requirement is a new policy that has been implemented by our program since the last inspection. Demonstration of acceptable corrective action (i.e., an updated benchsheet which included traceability for the pH buffers and Total Residual Chlorine reagents, standards and gel standards, and a statement that the preparation of the 2014 annual Total Residual Chlorine verification curve standards will be documented and the documentation kept for 5 years) was received by email on 2/25/2014. No further response is necessary for this finding. Proficiency Testing (PT) Comment: The laboratory is not designating the correct method code(s) for proficiency testing sample results. The Proficiency Testing Requirements, February 20, 2012, Revision 1.2 document states: To ensure that you are reporting the correct method, review your certificate attachment (i.e., certified parameter list). The method must include the entire method reference as is written on your certificate attachment (i.e., certified parameter list). This is a new policy that has been implemented by our program since the last inspection. Notification of acceptable corrective action (i.e., an email statement that for the entire method reference, as it appears on the certificate att achment, will be documented beginning with the 2014 PT results) was received by email on 2/25/2014. No further response is necessary for this finding. Page 3 #5378 DAK Americas Cedar Creek Comment: Designating the correct method code(s) will ensure you receive proper credit for the parameter method technologies on your current certificate attachment. When a PT provider utilizes a web-based submittal system, where the laboratory selects the analytical method from a pull-down list, it may be necessary to edit the choices given. Technical difficulties should be addressed with the PT provider. Comment: The laboratory is not documenting Proficiency Testing (PT) sample analyses in the same manner as environmental samples. The Proficiency Testing Requirements, February 20, 2012, Revision 1.2 document states: All PT sample analyses must be recorded in the daily analysis records as for any environmental sample. This serves as the permanent laboratory record. The analysis of PT samples is designed to evaluate the entire process used to routinely report environmental analytical results; therefore, PT samples must be analyzed and the process documented in the same manner as environmental samples. This is a new policy that has been implemented by our program since the last inspection. Notification of acceptable corrective action (i.e., an email statement that the lab will document PT sample analysis in the same manner as environmental samples beginning with the 2014 PT samples) was received by email on 2/25/2014. No further response is necessary for this finding. Comment: The preparation of Total Residual Chlorine (TRC) Proficiency Testing (PT) samples is not documented. The Proficiency Testing Requirements, February 20, 2012, Revision 1.2 document states: PT samples received as ampules must be diluted according to the PT provider’s instructions. The preparation of PT samples must be documented in a traceable log or other traceable format. The diluted PT sample becomes a routine environmental sample and is added to a routine sample batch for analysis. This is a new policy that has been implemented by our program since the last inspection. Notification of acceptable corrective action (i.e., an email statement that for the preparation of PT samples will be documented in a traceable log beginning with the 2014 PT samples) was received by email on 2/25/2014. No further response is necessary for this finding. Total Residual Chlorine – Standard Methods, 4500 Cl G-2000 Comment: The laboratory has been using the liquid reagents. At the time of the inspection, laboratory personnel indicated they will be switching to DPD powder reagents. This would be more economical in terms of both time and costs and will eliminate the need for calibrated pipettors. Use of the flow-thru cell could also be discontinued. Comment: The auto-pipettors have not been calibrated annually as required. The Quality Assurance Policies for Field Laboratories document states: Mechanical volumetric liquid-dispensing devices (e.g., fixed and adjustable auto-pipettors, bottle-top dispensers, etc.), used for critical measurements, must be calibrated at least every twelve months and documented. Each liquid-dispensing device must meet the manufacturer’s statement of accuracy. For variable volume devices used at more than one setting, check the accuracy at the maximum, middle and minimum values. Testing at more than three volumes is optional. When a device capable of variable settings is dedicated to dispense a single specific volume, calibration is required at that setting only. This is a new policy that has been implemented by our program since the last inspection. Notification of acceptable corrective action (i.e., an email statement that they will be switching to DPD powder and will consequently no longer be using the auto pipettors, effective March 5, 2014) was received by email on 2/25/2014. No further response is necessary for this finding. Comment: Concentrations less than the established reporting limit of 20 µg/L are being reported on the Discharge Monitoring Report (DMR). The NC WW/GW LC Approved Procedure for Analysis of Total Residual Chlorine document states: For analytical procedures requiring analysis of a series of standards, the concentrations of those standards must bracket the concentration of the samples analyzed. One of Page 4 #5378 DAK Americas Cedar Creek the standards must have a concentration equal to the laboratory’s lower reporting concentration for the parameter involved. Demonstration of acceptable corrective action (i.e., a benchsheet with a statement on the bottom to report results as <20 µg/L since the lowest calibration verification standard is 20 µg/L) was received by email on 2/25/2014. No further response is necessary for this finding. A. Finding: The gel standard used for the daily check standard was often outside the acceptance criterion and no corrective actions were taken. Requirement: The value obtained for the check standard must read within 10% of the true value of the check standard. If the obtained value is outside the +10% range, corrective action must be taken. Ref: NC WW/GW LC Approved Procedure for the Analysis of Total Residual Chlorine. Comment: The gel standard reading outside the acceptance criterion indicates a problem with either the gel standard or the meter. It is our belief that the consistent unacceptable reading of the gel standard indicates the problem is most likely with the meter. Troubleshooting and corrective action measures must be taken. Troubleshooting could consist of analyzing a known value sample from a PT provider to confirm the accuracy of the meter. If it is demonstrated that there is a problem with the meter, it must be serviced and repaired in accordance with North Carolina Administrative Code, 15A NCAC 2H .0805 (g) (4). Comment: Since the inspection, the laboratory has purchased a new gel standard and a true value has been assigned. The assigned gel standard value is 190 µg/L. This new gel standard has been reading within the acceptance criterion. A known value quality control standard has also been ordered from a PT provider to confirm the accuracy of the meter. Please submit a copy of the raw data for the known standard analysis (i.e., benchsheet documentation) and the results obtained with the true value assigned by the manufacturer upon completion. Comment: The gel standards must be verified initially and every 12 months thereafter, with the standard curve. When this is done, these standards may be used after the manufacturer’s expiration date. It is only necessary to verify the gel or sealed liquid standard which falls within the concentration range of the curve used to measure sample concentrations. The assigned values will be used for the next twelve months, or until a new curve verification is performed. The gel/liquid standard verification must be performed for each instrument on which they are to be used. Documentation must link the gel standard identification to the meter with which the assigned value was determined. B. Finding: Data that does not meet all quality control requirements is not qualified on the Discharge Monitoring Report (DMR). Requirement: When quality control (QC) failures occur, the laboratory must attempt to determine the source of the problem and must apply corrective action. Part of the corrective action is notification to the end user. If data qualifiers are used to qualify samples not meeting QC requirements, the data may not be useable for the intended purposes. It is the responsibility of the laboratory to provide the client or end-user of the data with sufficient information to determine the usability of the qualified data. Where applicable, a notation must be made on the Discharge Monitoring Report (DMR) form, in the comment section or on a separate sheet attached to the DMR form, when any required sample quality control does not meet specified criteria and another sample cannot be obtained. Ref: Quality Assurance Policies for Field Laboratories. Comment: The gel standard used for the daily check standard was consistently outside the acceptance criterion on the dates listed in the table below and the data was not qualified on the Page 5 #5378 DAK Americas Cedar Creek Discharge Monitoring Reports. It appears, from the values obtained for the check standard, that the Total Residual Chlorine results reported for environmental samples on these dates may be biased low (if it is determined during the troubleshooting process that the gel standard value was accurate). Date Assigned value of the Gel Standard Acceptable Range Value obtained August 1, 2013 233 µg/L 210 µg/L – 256 µg/L 197 µg/L August 10, 2013 233 µg/L 210 µg/L – 256 µg/L 196 µg/L August 16, 2013 233 µg/L 210 µg/L – 256 µg/L 194 µg/L August 20, 2013 233 µg/L 210 µg/L – 256 µg/L 202 µg/L September 9, 2013 233 µg/L 210 µg/L – 256 µg/L 203 µg/L September 12, 2013 233 µg/L 210 µg/L – 256 µg/L 202 µg/L September 19, 2013 233 µg/L 210 µg/L – 256 µg/L 197 µg/L September 25, 2013 233 µg/L 210 µg/L – 256 µg/L 199 µg/L October 5, 2013 233 µg/L 210 µg/L – 256 µg/L 198 µg/L October 10, 2013 233 µg/L 210 µg/L – 256 µg/L 201 µg/L October 17, 2013 233 µg/L 210 µg/L – 256 µg/L 203 µg/L October 26, 2013 233 µg/L 210 µg/L – 256 µg/L 204 µg/L November 28, 2013 233 µg/L 210 µg/L – 256 µg/L 212 µg/L Recommendation: It is recommended that you contact the Fayetteville Regional Office for guidance as to whether amended Discharge Monitoring Reports will be required, if it is found, during the troubleshooting process, that the meter was not operating properly. A copy of this report will be made available to the Regional Office. C. Finding: A reagent blank was not analyzed when the annual verification curve was analyzed on 5/3/2013. Requirement: A reagent blank (sometimes also referred to as a method blank) is only required when laboratory water is used to make quality control and/or calibration standards. If you are using a sealed standard (e.g., gel) for your daily check standard, a reagent blank would only be analyzed when preparing the annual 5-point calibration curve or 5 annual calibration curve verification standards. A reagent blank is made from the same laboratory water source used to make quality control and/or calibration standards with DPD. The concentration of reagent blanks must not exceed 50% of the reporting limit (i.e., the lowest calibration or calibration verification standard concentration), unless otherwise specified by the reference method, or corrective action must be taken. Ref: NC WW/GW LC Approved Procedure for the Analysis of Total Residual Chlorine. Please send a copy of the annual verification curve, including documentation of the reagent blank analysis, upon completion. pH – Standard Methods, 4500 H+B-2000 Comment: Values were reported that exceed the method specified accuracy of 0.1 units. Standard Methods, 4500 H+ B-2000, (6) states in part: However, ± 0.1 pH unit represents the limit of accuracy under normal conditions, especially for measurement of water and poorly buffered solutions. For this reason, report pH values to the nearest 0.1 pH unit. Notification of acceptable corrective action (i.e., a statement that pH results would be reported to 0.1 units) was received by e-mail on 2/25/2014. No further response is necessary for this finding. Page 6 #5378 DAK Americas Cedar Creek Temperature – Standard Methods, 2550 B-2000 Comment: The temperature correction is not posted the benchsheet or on the Dissolved Oxygen meter used to obtain reported temperature values. The NC WW/GW LC Approved Procedure for Temperature document states: The following must be documented in indelible ink whenever sample analysis is performed: The temperature correction (even if it is zero) must be posted on the meter as well as in hard copy format (to be retained for 5 years). Demonstration of acceptable corrective action (i.e., an updated benchsheet which included the temperature correction and a statement that the correction has been posted on the meter) was received by email on 2/25/2014. No further response is necessary for this finding. Comment: The temperature correction is not applied to the compliance sample results. The NC WW/GW LC Approved Procedure for the Analysis of Temperature document states: All thermometers and temperature measuring devices must be checked every 12 months against a National Institute of Standards and Technology (NIST) traceable thermometer. The process must be documented and proper corrections made to all compliance data. To check a thermometer or the temperature sensor of a meter, read the temperature of the thermometer/meter against a NIST traceable thermometer and record the two temperatures. The verification must be performed in the approximate range of the sample temperatures measured. The thermometer/meter readings must be less than or equal to 1ºC from the NIST traceable thermometer reading. The documentation must include the serial number of the NIST traceable thermometer that was used in the comparison. Demonstration of acceptable corrective action (i.e., an updated benchsheet which included the statement that the temperature correction would be applied to all reported sample measurements) was received by email on 2/25/2014. No further response is necessary for this finding. Recommendation: It is recommended that you contact the Fayetteville Regional Office for guidance as to whether amended Discharge Monitoring Reports will be required. A copy of this report will be made available to the Regional Office. IV. PAPER TRAIL INVESTIGATION: The paper trail consisted of comparing laboratory benchsheets and contract lab reports to Discharge Monitoring Reports (DMRs) submitted to the North Carolina Division of Water Resources. Data were reviewed for July and September, 2013. No transcription errors were detected. The facility appears to be doing a good job of accurately transcribing data. V. CONCLUSIONS: Correcting the above-cited findings and implementing the recommendations will help this lab to produce quality data and meet certification requirements. The inspector would like to thank the staff for its assistance during the inspection and data review process. Please respond to all findings. Report prepared by: Tonja Springer Date: March 14, 2014 Report reviewed by: Nick Jones Date: March 20, 2014